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5/20/2019

Acetylcysteine Oral and Inhalation Solution

Products Affected - Description

    • Cetylev oral effervescent tablet, Arbor, 2.5 gram, packet, 20 count, NDC 24338-0725-10 - discontinued
    • Cetylev oral effervescent tablet, Arbor, 500 mg, packet, 20 count, NDC 24338-0700-10 - discontinued
    • Acetylcysteine solution, American Regent, 100 mg/mL, 4 mL vial, 25 count, NDC 00517-7504-25
    • Acetylcysteine solution, American Regent, 200 mg/mL, 30 mL vial, 3 count, NDC 00517-7630-03
    • Acetylcysteine solution, American Regent, 200 mg/mL, 4 mL vial, 3 count, NDC 00517-7604-25
    • Acetylcysteine solution, Fresenius Kabi, 100 mg/mL, 30 mL vial, 3 count, NDC 63323-0691-30
    • Acetylcysteine solution, Fresenius Kabi, 100 mg/mL, 4 mL vial, 25 count, NDC 63323-0695-04

Reason for the Shortage

    • American Regent has acetylcysteine oral and inhalation solution on shortage due to manufacturing delays.
    • Arbor discontinued Cetylev effervescent tablets in April 2019.
    • Fresenius Kabi has acetylcysteine oral and inhalation solution available.
    • Pfizer had acetylcysteine oral and inhalation solution on shortage due to manufacturing delays.
    • Roxane Labs discontinued acetylcysteine oral and inhalation solution in April 2014.

Available Products

    • Acetylcysteine solution, Fresenius Kabi, 100 mg/mL, 10 mL vial, 3 count, NDC 63323-0693-10
    • Acetylcysteine solution, Fresenius Kabi, 200 mg/mL, 10 mL vial, 3 count, NDC 63323-0692-10
    • Acetylcysteine solution, Fresenius Kabi, 200 mg/mL, 30 mL vial, 3 count, NDC 63323-0690-30
    • Acetylcysteine solution, Fresenius Kabi, 200 mg/mL, 4 mL vial, 3 count, NDC 63323-0694-04
    • Acetylcysteine solution, Pfizer, 100 mg/mL, 30 mL vial, 3 count, NDC 00409-3307-03
    • Acetylcysteine solution, Pfizer, 200 mg/mL, 30 mL vial, 3 count, NDC 00409-3308-03

Estimated Resupply Dates

    • American Regent has acetylcysteine solution 100 mg/mL 4 mL vials available in limited supply. The 200 mg/mL 4 mL and 30 mL vials are on back order and the company cannot estimate a release date.
    • Fresenius Kabi has short-dated acetylcysteine 100 mg/mL 4 mL and 30 mL vials available with an expiration date of <5 months.

Updated

Updated May 20, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. Created June 28, 2011 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2019, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Vizient to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Vizient, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Vizient, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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